510(k) · Cleared
ClearedStryker SE5 Arthroscopy System with Hermes Voice Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · GCJ Laparoscope, General & Plastic Surgery
Cleared on May 29, 1998 as substantially equivalent to K941333 (Stryker Endoscopy, 1994) and 2 other predicates after a 158-day review. Its family tree reaches back 2 generations to 1993. 254 later devices descend from it.
- Decided
- May 29, 1998
- Review
- 158 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K931783 (1993). 3 ancestors in all. 254 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 1 generation backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- This deviceK974771 Stryker SE5 Arthroscopy System with Hermes Voice ControlStryker Endoscopy · 1998
- Descendant · cites it directly · 253 of its ownK991696 Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999
- Descendant · 2 generations on · 238 of its ownK032117 Stryker Total Performance (TPS) SystemStryker Instruments · 2003
- Descendant · 2 generations on · 226 of its ownK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
- Descendant · 3 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- Descendant · 4 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
Showing 5 of 254 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 254 · See all- K991696Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999 · cites it directly253descendants
- K032117Stryker Total Performance (TPS) SystemStryker Instruments · 2003 · 2 generations on238descendants
- K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004 · 2 generations on226descendants
- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 3 generations on221descendants
- K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 4 generations on202descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −1 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| 0 (this device) | K974771 | Stryker SE5 Arthroscopy System with Hermes Voice Control | Stryker Endoscopy | 1998 | — |
| +1 | K991696 | Stryker Hermes-Ready Total Performance System | Stryker Instruments | 1999 | — |
| +2 | K032117 | Stryker Total Performance (TPS) System | Stryker Instruments | 2003 | — |
| +2 | K040270 | Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum | Lumenis, Ltd. | 2004 | — |
| +3 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| +4 | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 11 | 0 |
| 2009 | 3 | 0 |
| 2010 | 10 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 9 | 0 |
| 2014 | 9 | 0 |
| 2015 | 11 | 0 |
| 2016 | 11 | 0 |
| 2017 | 8 | 0 |
| 2018 | 11 | 0 |
| 2019 | 7 | 0 |
| 2020 | 14 | 0 |
| 2021 | 12 | 0 |
| 2022 | 24 | 0 |
| 2023 | 15 | 0 |
| 2024 | 28 | 0 |
| 2025 | 33 | 0 |
| 2026 | 15 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GCJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K941333 | SE5 Arthroscopy SytemSummary page 1…throscopy System with HERMES Voice Control Classification Name: Surgical instrument motors and accessories/attachments 3) Substantially equivalent to SE 5 Shaver 510(k) 941333, AESOP 510(k)’s K931783 and K960655 4) The SES Arthroscopy and Small Joint Debrider Systems are electrically powered instrumenta… | 1994 |
| * | K931783 | Aesop (Automated Endoscopic System for Optimal PosSummary page 1…ERMES Voice Control Classification Name: Surgical instrument motors and accessories/attachments 3) Substantially equivalent to SE 5 Shaver 510(k) 941333, AESOP 510(k)’s K931783 and K960655 4) The SES Arthroscopy and Small Joint Debrider Systems are electrically powered instrumentation specifically design… | 1993 |
| * | K960655 | Aesop System and AccessoriesSummary page 1…Control Classification Name: Surgical instrument motors and accessories/attachments 3) Substantially equivalent to SE 5 Shaver 510(k) 941333, AESOP 510(k)’s K931783 and K960655 4) The SES Arthroscopy and Small Joint Debrider Systems are electrically powered instrumentation specifically designed for intra… | 1996 |
What descends from it? (254)
See all 2541 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991696 | Stryker Hermes-Ready Total Performance System | 1999 | 253 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K991696 (Stryker Instruments, 1999) has gone furthest, with 253 descendants of its own.
- 1 other device also cites its predicate K941333.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
Indications for use of the SE5 Small Joint Shaver in the wrist are any need for morselization of tissue within the joint. Cutters will be used to debride synovitis, articular cartilage flaps, or torn ligaments when surgeons deem resection appropriate. Burs are indicated for management of osseous lesions such as eburnated articular surfaces or osteophytes.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974771 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974771: Stryker SE5 Arthroscopy System with Hermes Voice Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974771
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026